Manufactured to shape headgear and masks

ABSTRACT

A headgear or headgear segments are manufactured to shape thereby producing little or no waste material. Techniques such as knitting, braiding, crocheting, and 3D printing can be used produce the headgear.

CROSS-REFERENCE TO APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/240,065 filed Feb. 21, 2014 (allowed), which is the U.S. nationalphase of International Application PCT/AU2012/000979, filed Aug. 21,2012 which designated the U.S. and claims the benefit of U.S.Provisional Application No. 61/670,495, filed Jul. 11, 2012 and U.S.Provisional Application No. 61/526,057, filed Aug. 22, 2011. Eachapplication mentioned above is incorporated herein by reference in itsentirety.

FIELD OF TECHNOLOGY

The present technology relates to headgear and masks, and a method ofmanufacturing such for use in treatment, e.g., of Sleep DisorderedBreathing (SDB) with Continuous Positive Airway Pressure (CPAP) orNon-Invasive Positive Pressure Ventilation (NIPPV).

BACKGROUND OF TECHNOLOGY

Masks used for treatment of SDB such as Obstructive Sleep Apnea (OSA)are typically held on a patient's head by headgear. Headgear typicallyincludes one or more headgear straps that are adapted to engage with themask and hold the mask in position on the patient's face. In addition,headgear should be comfortable so that a patient can wear the mask atnight while they sleep. There is a continuous need in the art forheadgear that is comfortable, fits a wide range of patients, is easilymanufactured, and is inexpensive.

Known methods of manufacturing headgear involve cutting headgearcomponents 1020 from a sheet of fabric 1000, as shown in FIG. 1 . Aproblem with this method is that it renders a relatively large portionof the sheet 1000 to waste. While waste can be minimized by nesting theheadgear pieces as closely as possible on the sheet 1000, the cuttingstep required in this process ensures that waste material will beproduced. In manufacturing headgear in a conventional manner, severaldifferent materials and several different manufacturing processes mustbe used. In manufacturing headgear, considerable time and labor isrequired to cut the components and sub-components to an appropriate sizeand shape, and to stitch or bond or laminate these elements to eachother. These techniques are time, labor, and process intensive, and thecutting or trimming process usually results in an undesirable amount ofwaste compared to the part of the material actually used, even withappropriate nesting of components.

SUMMARY OF TECHNOLOGY

An aspect of the disclosed technology relates to a fabric component foruse with a mask system.

Another aspect of the disclosed technology relates to a headgear for usewith a mask system.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgearcomprises at least one component (e.g., strap, crown portion, otherhead/face contacting portions) formed of a single unitary, seamlessstructure.

Another aspect of the disclosed technology relates to knitting variousheadgear sections in a continuous manner so that there are no or veryfew additional manufacturing steps that would be required to sew, fuse,adhere or otherwise attach adjoining sections. As a result, themanufacturing process may have reduced steps, the amount of materialwaste is reduced, there would be virtually no seams in the headgearbetween the adjoining sections, and the headgear made of a fabricwithout distinctive joins or seams may be more comfortable for patients.

Another aspect of the disclosed technology relates to knitting variousheadgear sections in a continuous manner i.e. forming a single, unitaryseamless structure having at least two regions, wherein the at least tworegions extend from a junction at different angular orientations. Forexample, a first strap may extend in a substantially horizontaldirection and a second strap may extend in a substantially verticaldirection, the first strap and the second strap being formed as asingle, unitary seamless structure formed in a continuous process (e.g.knitting).

Another aspect of the disclosed technology relates to knitting variousheadgear sections in a continuous manner i.e. forming a single, unitaryseamless structure having at least two regions, wherein the at least tworegions branch out or extend at different angles or in differentdirections to one another.

Another aspect of the disclosed technology relates to a headgear for amask, the headgear being constructed of a textile formed frommechanically manipulated yarn.

A further aspect of the disclosed technology relates to a headgear for amask, the headgear being constructed of a textile formed frommechanically manipulated yarn by interlooping, including knitting.

A further aspect of the disclosed technology relates to a headgear for amask, the headgear being constructed of a textile formed frommechanically manipulated yarn by interweaving.

A further aspect of the disclosed technology relates to a headgear for amask, the headgear being constructed of a textile formed frommechanically manipulated yarn by intertwining, including braiding andknotting.

Another aspect of the disclosed technology relates to a method ofmanufacturing headgear comprising forming a textile to shape (e.g.,formed in one piece to shape without cutting, by mechanical manipulationof yarn including means of but not limited to interlooping,interweaving, intertwining, including for example knitting, crochet,braiding, weaving or additive manufacturing/3D printing), wherein thetextile is adapted to support, in use, a mask on a patient's face.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgearcomprises a strap at least partly constructed of spacer fabric.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgearcomprises a strap at least partly constructed of spacer fabric, thespacer fabric being formed by a first and second ground layer orstructure, the first and second ground layers or structures beingsubstantially parallel.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgearcomprises a strap at least partly constructed of spacer fabric, thespacer fabric being formed by a first and second ground layer orstructure, the first and second ground layers or structures beingsubstantially parallel, the first and second ground layers or structureshaving different stiffnesses.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgearcomprises a strap at least partly constructed of spacer fabric, thespacer fabric being formed by a first and second ground layer orstructure, and further comprising a traversing or floating yarn or pileadapted to connect the first and second ground layers or structures.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgearcomprises a strap at least partly constructed of spacer fabric, whereinthe spacer fabric is formed by knitting.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgearcomprises a strap at least partly constructed of spacer fabric, whereinan outer surface of the headgear may be formed from, for example, about30-100, 20-300, or 50-200 denier yarn for a pleasant hand feel.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgearcomprises at least a first yarn and a second yarn, the first yarn havinga first stiffness and the second yarn having a second stiffness.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgear isformed by flat knitting or circular knitting.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgear isformed by flat knitting. The headgear may further comprise pockets,tunnels, layers and/or ribs. Furthermore, the pockets or tunnels may bereinforced with stiffer materials to add rigidity to the headgear.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgear isformed by flat knitting or circular knitting. The headgear may furthercomprise pockets, tunnels, layers and/or ribs. The pockets or tunnelsmay be cushioned by filling the pockets or tunnels with padding,including floating yarn, looped yarn, foam or other cushioning material.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgear isformed by flat knitting or circular knitting, further wherein theheadgear has selvedges, that is, ends of the yarn are distal to the edgeof the headgear to prevent unraveling or fraying.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, wherein the headgear isformed by a regular or irregular pique knit so the yarn exposed on theright side is different to the yarn exposed on the wrong side. Forexample, the yarn on the right side may have a pleasant visualappearance and the yarn on the wrong side may have a nice hand feel forcontacting the patient's skin. Alternatively, or in addition, the yarnon the right side may have a first moisture wicking property and thewrong side may have a second moisture wicking property. For example, theyarn on the right side may have a high percentage of microfiber having afirst moisture wicking property and the wrong side may have a highpercentage of non-microfiber having a second moisture wicking property.

Another aspect of the disclosed technology relates to a headgear for usein supporting a respiratory mask in position on a patient's face, theheadgear being constructed of a yarn, the headgear having a first regionwith a first density of yarn and a second region with a second densityof yarn. The region with the greater density of yarn may have lessextensibility, less permeability and higher stiffness.

Another aspect of the disclosed technology relates to a headgear for usein supporting a respiratory mask in position on a patient's face, theheadgear being constructed of a first yarn and a second yarn, theheadgear having a first region constructed of the first yarn, the firstyarn having a first denier and a second region constructed of the secondyarn, the second yarn having a second denier.

Another aspect of the disclosed technology relates to a headgear for usein supporting a respiratory mask in position on a patient's face, theheadgear being constructed of a first yarn and a second yarn, theheadgear having a first region constructed of the first yarn, the firstyarn having a first twist per inch property and a second regionconstructed of the second yarn, the second yarn having a second twistper inch property.

Another aspect of the disclosed technology relates to a headgear for usein supporting a respiratory mask in position on a patient's face, theheadgear being constructed of a yarn, the yarn comprising texturedfilaments. The textured filaments may improve hand feel and alter thestretch characteristics of the headgear.

Another aspect of the disclosed technology relates to a method offorming a headgear for use in supporting a respiratory mask in positionon a patient's face, comprising the steps of knitting the headgear witha water soluble yarn, dissolving at least an edge of the headgear inwater, and drying the headgear (thereby causing it to shrink). Theshrinkage of the edge of the headgear may result in a finished edge.

Another aspect of the disclosed technology relates to a method offorming headgear for use in holding a respiratory mask in position on apatient's face and comprising a) knitting a yarn or thread to form aheadgear component (e.g., a strap) adapted to at least partially supportthe mask, the component being connected to an attachment member, theattachment member adapted to connect the component to the mask; and instep a), looping the yarn or thread through a connecting portion formedin the attachment member to connect the component to the attachmentmember.

Another aspect of the disclosed technology relates to a mask system foruse in treating a patient for sleep disordered breathing comprising amask assembly adapted to seal against the patient's face thereby forminga breathing cavity, the mask having one or more portions constructed ofa first knitted fabric; and a headgear connected to the mask to at leastpartially support the mask on the patient's face, the headgear havingone or more portions constructed of at least one of the first knittedfabric and a second knitted fabric.

Another aspect of the disclosed technology relates to a mask system foruse in treating a patient for sleep disordered breathing comprising amask assembly adapted to seal against the patient's face thereby forminga breathing cavity, the mask having one or more portions constructed ofa first knitted fabric; and a headgear connected to the mask to at leastpartially support the mask on the patient's face, the headgear havingone or more portions constructed of at least one of the first knittedfabric and a second knitted fabric. The first knitted fabric may bejoined to the second knitted fabric by interlooping and preferablyhaving a seamless connection or join, for example a tuck stitch.

Another aspect of the disclosed technology relates to a method offorming headgear for use in holding a respiratory mask in position on apatient's face and comprising knitting a yarn or thread to form aheadgear component adapted to at least partially support the mask,wherein a grain or course of the knit is altered to form a curvedportion of the headgear component.

Another aspect of the disclosed technology relates to a method offorming headgear for use in holding a respiratory mask in position on apatient's face and comprising knitting a yarn or thread to form aheadgear component adapted to at least partially support the mask,wherein a grain or course of the knit is arranged to allow or disallowstretch in at least one portion of the headgear component.

Another aspect of the disclosed technology relates to headgear for usein supporting a respiratory mask in position on a patient's face forpositive pressure treatment of the patient, the headgear comprising afirst component at least partly constructed of spacer fabric, the spacerfabric including an inner fabric, an outer fabric and an inner spacerfiber interconnecting the outer fabric and the inner fabric, wherein theinner fabric delimits a hollow interior area.

Another aspect of the disclosed technology relates to a method offorming headgear for use in holding a respiratory mask in position on apatient's face, comprising knitting a yarn or thread to form a headgearcomponent adapted to at least partially support the mask, the headgearcomponent being at least partly constructed of spacer fabric and havingan inner layer formed of spacer yarns; and altering a length or densityof the spacer yarns in at least one portion of the headgear component tovary an attribute of the headgear component.

Another aspect of the disclosed technology relates to a mask assemblyfor use in treating a patient for sleep disordered breathing comprisingone or more portions constructed of spacer fabric, the spacer fabrichaving an inner layer formed of spacer yarns, the inner layer having atleast one portion forming a vent hole, wherein the at least one portionis substantially void of spacer yarns.

Another aspect of the disclosed technology relates to a method offorming headgear for use in holding a respiratory mask in position on apatient's face and comprising knitting a yarn or thread to form a firstknitted fabric; concurrently knitting a yarn or thread to form a secondknitted fabric; and at the same time, knitting the first knitted fabricto the second knitted fabric such that one of the first knitted fabricand the second knitted fabric forms an inner fabric adapted to interfacewith the patient.

Another aspect of the disclosed technology relates to a method offorming headgear for use in holding a respiratory mask in position on apatient's face and comprising knitting a yarn or thread to form aheadgear component adapted to at least partially support the mask; andaltering a number of stitches in at least one portion of the headgearcomponent to vary an attribute of the headgear component.

Another aspect of the disclosed technology relates to a method offorming headgear for use in holding a respiratory mask in position on apatient's face and comprising knitting a yarn or thread to form aheadgear component adapted to at least partially support the mask; andaltering a thread count or stitch style in at least one portion of theheadgear component to vary an attribute of the headgear component.

Another aspect of the disclosed technology relates to a headgearassembly for use in supporting a respiratory mask in position on apatient's face for positive pressure treatment of the patient, theheadgear comprising a first headgear component constructed of a knittedfabric, the knitted fabric including a first yarn or thread and a secondyarn or thread having a higher stiffness than the first yarn or thread,wherein the second yarn or thread is arranged to provide a rigidizingportion of the first headgear component.

Another aspect of the disclosed technology relates to a method offorming headgear for use in holding a respiratory mask in position on apatient's face and comprising providing a base headgear material to forma headgear component adapted to at least partially support the mask; andthen either (but not limited to) knitting, embroidering or weaving ayarn or thread into the base headgear material, the yarn or threadhaving a higher stiffness than the base material, wherein the yarn orthread is arranged to provide a rigidizing portion of the headgearcomponent.

Another aspect of the disclosed technology relates to a headgearassembly for use in supporting a respiratory mask in position on apatient's face for positive pressure treatment of the patient, theheadgear comprising a first yarn, the first yarn being formed from athermoplastic, wherein the thermoplastic yarn may be fused to create arigidized portion of the headgear component.

Another aspect of the disclosed technology relates to a method offorming headgear for use in holding a respiratory mask in position on apatient's face and by using “additive manufacturing” or “rapidmanufacture” or “3D printing” processes (these terms are able to be usedinterchangeably in colloquial language) to create a textile which formsat least a first headgear component adapted to at least partiallysupport the mask.

Still another aspect of the disclosed technology relates to a method ofmanufacturing custom headgear for use in holding a respiratory mask inposition on a patient's face and comprising acquiring data related tothe shape and size of the patient's head; creating an electronicheadgear model with a computing device and computer aided design programin accordance with the acquired data; and forming at least a firstheadgear component corresponding at least in part to the electronicheadgear model.

Another aspect of the disclosed technology relates to a method ofmanufacturing a series of headgear for use in holding a respiratory maskin position on a patient's face and comprising knitting a first headgearor headgear component, knitting a knit release, knitting a secondheadgear or headgear component and separating the first headgear orheadgear component from the second headgear or headgear component at theknit release.

Another aspect of the disclosed technology relates to a component (e.g.,headgear, mask, tube, cushion) that may be formed via processes such asknitting, weaving, crochet or embroidery in order to include the use ofone or several types of yarns with various unique properties, such asconductivity. For example, a conductive yarn or thread which isintegrated into the overall form of the component might be used forconveying electricity and/or data to and from, for example, similarlyintegrated or add-on: sensors, heating elements, cooling elements,tensioning systems, on/off buttons, power sources, computer chips,controllers etc.

Other aspects, features, and advantages of this technology will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thistechnology.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this technology. In such drawings:

FIG. 1 shows a prior art example of headgear pieces cut from a fabricsheet;

FIG. 2 is a perspective view of a headgear manufactured according to anexample of the disclosed technology;

FIG. 3 shows a process of manufacturing a headgear according to anotherexample of the disclosed technology;

FIG. 4-1 shows a process of forming headgear straps from a continuousroll according to an example of the disclosed technology;

FIG. 4-2 shows a strap according to an example of the disclosedtechnology;

FIG. 4-3 is a cross-sectional view along the line 4-3 to 4-3 of FIG. 4-2;

FIG. 4-4 is a cross-sectional view of a strap according to analternative example of the disclosed technology;

FIG. 4-5 shows a strap according to an example of the disclosedtechnology;

FIG. 4-6 is a cross-sectional view along the line 4-6 to 4-6 of FIG. 4-5;

FIG. 4-7 is a cross-sectional view of a strap according to analternative example of the disclosed technology;

FIG. 4-8 is a cross-sectional view of a strap according to analternative example of the disclosed technology;

FIG. 5-1 is a perspective view showing attachment of headgear to a maskin according to an example of the disclosed technology;

FIG. 5-2 shows a lower headgear clip according to an example of thedisclosed technology;

FIG. 6 is a front view of an integral headgear and mask system inposition on a patient's head according to an example of the disclosedtechnology;

FIGS. 7 and 8 are conventional examples depicting the knitting process;

FIG. 9-1A illustrates a basic warp knitted fabric according to anexample of the disclosed technology;

FIG. 9-1B is a schematic representation of the basic warp knitted fabricof FIG. 9-1A;

FIG. 9-2 illustrates a basic warp knitted fabric according to an exampleof the disclosed technology;

FIG. 10 illustrates a basic weft knitted fabric according to an exampleof the disclosed technology;

FIG. 11 is a side view of headgear positioned on a patient's head inaccordance with an example of the disclosed technology;

FIG. 11A shows the changing direction of the course or grain of theheadgear of FIG. 11 according to an example of the disclosed technology;

FIG. 12 illustrates an increased stretch in the direction of the courseof a knitted headgear according to an example of the disclosedtechnology;

FIGS. 13 and 13 a show headgear according to an example of the disclosedtechnology;

FIGS. 14-1 to 14-4 shows one way of manufacturing headgear formed as atube via circular warp knitting according to examples of the disclosedtechnology;

FIG. 14-5 is a cross-sectional view of a strap according to an exampleof the disclosed technology;

FIG. 14-6 is partial view of a strap according to an example of thedisclosed technology;

FIG. 14-6A is a cross-sectional view along the line 14-6A-14-6A in FIG.14-6 ;

FIGS. 15-1 to 15-5 show headgear including portions having variablethicknesses according to examples of the disclosed technology;

FIG. 16 is a front view of a mask which may or may not include a ventcomponent according to an example of the disclosed technology;

FIG. 17 is a cross-sectional view along the line 17-17 of FIG. 16 ;

FIG. 18 is a cross-sectional view of a headgear piece having thinnedregions according to an example of the disclosed technology;

FIG. 19 is a cross-sectional view of a headgear piece having more denseand less dense regions according to an example of the disclosedtechnology;

FIG. 20 is a cross-sectional view along the line 20-20 of FIG. 5-1 ;

FIG. 21 is a cross-sectional view along the line 21-21 of FIG. 6 ;

FIG. 22-1 is a schematic representation of a double knit headgear ormask component according to an example of the disclosed technology;

FIGS. 22-2A and 22-2B illustrate an interlock knit headgear or maskcomponent according to an example of the disclosed technology;

FIG. 23 is a front view of headgear and a mask in position on apatient's head according to an example of the disclosed technology;

FIG. 24 is a side view of the headgear and mask of FIG. 23 ;

FIG. 25-1 is a side view of headgear including a rigidizer in positionon a patient's head according to an example of the disclosed technology;

FIG. 25-2 is an enlarged view of the headgear of FIG. 25-1 ;

FIG. 26 illustrates a process of forming a rigidizer in headgearaccording to an example of the disclosed technology;

FIG. 27 illustrates a process of forming a curved rigidizer in headgearaccording to an example of the disclosed technology;

FIG. 28 shows 3D printed links used to form headgear according to anexample of the disclosed technology;

FIG. 29 shows a 3D printed headgear piece including a rigidizeraccording to an example of the disclosed technology; and

FIG. 30 shows 3D printed headgear straps and clips according to anexample of the disclosed technology.

DETAILED DESCRIPTION OF ILLUSTRATED EXAMPLES

The following description is provided in relation to several exampleswhich may share common characteristics and features. It is to beunderstood that one or more features of any one example may becombinable with one or more features of the other examples. In addition,any single feature or combination of features in any of the examples mayconstitute an additional example or examples.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including”, and thus not limitedto its “closed” sense, that is the sense of “consisting only of”. Acorresponding meaning is to be attributed to the corresponding words“comprise”, “comprised” and “comprises” where they appear.

1. Headgear

The figures illustrate headgear according to examples of the disclosedtechnology. In the illustrated examples, headgear are adapted to beremovably attached to a patient interface to hold and maintain thepatient interface in a desired position on a patient's face. Whileheadgear may be illustrated as being used with a particular type ofpatient interface (e.g., mask), it should be appreciated that eachheadgear may be adapted for use with other suitable patient interfaces.That is, the patient interfaces are merely exemplary, and each headgearembodiment may be adapted for use with any suitable patient interface,e.g., full-face mask, nasal mask, mouth mask, nozzles or puffs, nasalprongs, etc, with any suitable configuration, e.g., with or withoutforehead support.

Also, it should be appreciated that the headgear may be used with a newpatient interface or the headgear may be retrofit to an existing patientinterface.

2. Manufacturing

An example of a headgear 200 manufactured according to an example of thedisclosed technology is shown in FIG. 2 . The headgear includes a rearportion for example a “crown” or “halo” 210 and a plurality of straps220 attached to the rear portion. The rear portion 210 is adapted toaccommodate the patient's occiput and the straps 220 are configured toconnect to upper and lower headgear attachment points (e.g. clips), asone skilled in the art will understand. It is noted that the headgear200 is merely an example and that other headgear configurations may bemade in accordance with the disclosed technology.

The headgear 200 is manufactured to shape (e.g., formed in one piece toshape otherwise known as “fully-fashioning” without the need to cut awayany substantial amounts of material) thereby producing little or nowaste material. Alternatively, the headgear may be divided into segmentsthat are each manufactured to shape separately (e.g., by knitting) andthen attached to one another. FIG. 2 demonstrates a single, unitaryseamless structure having at least two regions (e.g. the rear portion210 and straps 220), wherein the at least two regions extend from ajunction (the junction being the connection between the straps 220 andthe rear portion 210), where the straps extend at a different angularorientation to the rear portion. The rear portion and straps are formedin a continuous process (i.e. the material that makes up the componentand the shape of the component are formed in a single step)—this isdifferent to a process where a sheet of material is made and then cut toshape (this would not be considered a single step). FIG. 2 also showsthat the straps 220 branch out or extend at a different angle ordirection to the rear portion 210, without requiring seams or additionalformation steps.

In FIG. 3 , the rear portion 210 and the straps 220 are formedseparately and subsequently connected. One skilled in the art willunderstand that any portions of the headgear 200 can be formedseparately and then later connected. In the example of FIG. 3 , thestraps 220 are stitched to the rear portion 210; however other suitablemethods such as knitting, sewing, crocheting, heat bonding with adhesivetape, gluing, welding (e.g., ultrasonic welding), etc. may be used.

A knitted component such as headgear is defined as being formed of“unitary knit construction” when constructed as a one-piece knit elementthat is substantially free of additional stitching or bonding processes.

As shown in FIG. 4-1 , the straps 220 may be formed (e.g., by warpknitting) as a continuous piece that is subsequently cut as thisprocedure may further increase manufacturing efficiency.

Knitting various headgear sections in a continuous manner may beadvantageous as there are no or very few additional manufacturing stepsthat would be required to sew, fuse, adhere or otherwise attachadjoining sections. As a result, the manufacturing process may havereduced steps, the amount of material waste is reduced, there would bevirtually no seams in the headgear between the adjoining sections, andthe headgear made of a fabric without distinctive joins or seams may bemore comfortable for patients.

2.1 Techniques

A number of techniques can be used in accordance with the presenttechnology to manufacture headgear to shape with little or no wastematerial. Preferably, the technique may produce a headgear that is asingle, unitary, seamless structure. Techniques that may produce asingle unitary seamless structure include mechanical manipulation ofyarn including interlooping (such as knitting), interweaving and/orintertwining (including braiding, knotting and crocheting). Analternative technique of 3D printing may also create a headgear having aunitary, seamless structure.

A manufacturing technique in accordance with the disclosed technologypreferably has one or more of the following features:

-   -   1) produces little or no waste;    -   2) produces headgear that is comfortable for the patient;    -   3) produces headgear that is conformable;    -   4) produces headgear that is breathable;    -   5) produces headgear that may minimizes facial marking; and/or    -   6) produced headgear that is lightweight.        2.1.1 Interlooping—Knitting

In accordance with an example of the disclosed technology, headgear maybe formed by interlooping such as knitting (e.g., threading yarn orthread to form a knitted fabric). The headgear may be formed by flatknitting or circular knitting, however other forms of knitting may alsobe possible. Flat knitting and circular knitting may be preferable asthey are able to create a headgear with a unitary, seamless structure.Flat or circular knitting machines may be utilized to create a weft knitor a warp knit. A variety of knitting processes including circularknitting and warp- or weft-flat knitting, may be utilized to manufacturethe headgear component or components. Flat knitting may have someadvantages, including but not limited to (1) the ability to locatefloating yarns within, for example, a headgear strap, in order toprovide extra cushioning or bulk, and/or (2) the ability to includeextra loops of yarns on either the upper or lower surface of theheadgear strap, thus creating the effect of a soft terry cloth material,for example, or creating an unbroken loop fabric for engagement with ahook tape fastener, and/or (3) the ability to knit a 3D dimensionalspacer fabric construction adjacent to double-faced knit constructionwithin a single unified headgear construction.

Preferably, the headgear is formed primarily from multiple yarns thatare mechanically manipulated through an interlooping process to producea single unitary structure having various sections with differentphysical properties.

FIG. 7 illustrates the wale of a weft knit fabric 70, or the directionthat the loops of one thread join to a loop of another thread. Thecourse 80, or the direction of the loops from a single thread is shownin FIG. 8 . FIGS. 9-1A and 9-1B illustrate a basic closed loop warp knit90. FIG. 9-2 illustrates an example of a warp knit tricot jersey fabricstructure in which a yarn is knitted in a vertical direction in azig-zag manner, capturing other warp yarns, with the wale runningsomewhat parallel to the course.

Referring to FIGS. 9-1A, 9-1B, 9-2 and 10 , a warp knit 90, 90-1comprises the wales and courses running parallel to one another, whilein a weft knit 100 the wales run perpendicular to the course. Theheadgear and masks of the disclosed technology may be formed by eitherwarp knit or weft knit. A warp knit, for example tricot, raschel orlocknit, is typically more resistant to runs, easy to machine, and mayutilize multiple yarns (allowing for the use of multiple colors or yarntypes). A weft knit can be formed with a single yarn; however, use ofmultiple yarns is also possible. The headgear of the disclosedtechnology may be constructed of a warp knit or a weft knit.

Knitted fabrics may have different stretchability characteristicscompared to woven fabrics. Knitted fabrics are typically more flexiblethan woven fabrics, which may only stretch in one direction (dependingon the yarn they are made from), and therefore may provide a morecomfortable fit for the patient. Knitted textiles may be constructed insuch a way that the fabric has a two-way stretch—i.e. a first yarnoriented in a first direction has a lower flexibility than a yarnoriented in a second direction. This arrangement may be desirable alongthe straps of the headgear such that the straps can stretch along theirlength but not across their width, or vice versa. Alternatively, theknitted textile may have a four-way stretch i.e. yarn in a firstdirection and a second direction and both are flexible such thatapplication to a strap would allow stretch in both lengthwise andcrosswise directions.

The example of FIG. 12 shows a strap 1200 having a grain or course 1250,and illustrates how the direction of the grain or course affectsstretch. The knitted fabric will tend to stretch more readily in thedirection of the course. Therefore, headgear may be designed to stretchin certain directions and be more resistant to stretch in otherdirections. For example, the strap 1200 will tend to stretch in itswidth direction A (from the patient's face to the back of the head) andmay have limited stretch along the length of the strap. Thisconfiguration may increase stability of the headgear in the lengthwisedirection while increasing fit range. The strap 1200 may be configuredto stretch in certain directions and be resistant to stretch in otherdirections in order to better enable the strap 1200 to hold a maskassembly on a patient's face in a manner that enhances the seal with thepatient's face.

Referring to FIGS. 5-1 and 5-2 , a mask 510 is held in position on apatient's face by headgear 520. The mask 510 includes an elbow couplingportion 512 adapted to connect to an elbow (not shown) for supplyingpressurized air to the mask. Lower mask clips 514 are adapted to connectto the headgear 520.

The headgear 520 includes upper headgear straps 530 and lower headgearstraps 540 configured for connection to the mask 510. An attachmentmember 544 (e.g., a lower headgear clip) may have connecting portions544(1) (e.g., holes) for receiving the strap material (e.g., thread oryarn). For example, yarn comprising the lower headgear strap may belooped through the holes 544(1) during fabrication of the strap tointegrate the clip 544 and the strap 540.

In an alternative example shown in FIG. 6 , a mask 610 and headgear 630are integrally formed as one piece. The mask 610 is knit to include openareas which function as vent holes 612. An elbow coupling portion 614includes holes 614(1) for receiving the yarn or thread therebyintegrating the mask 610 and elbow coupling portion 614. The mask may bemade air tight by laminating or other suitable methods.

The headgear 630 includes crown straps 632, 634, top strap 640, andlower headgear straps 650. The knit may be pulled tight or formedloosely to adjust the fit and enhance comfort in certain areas. Forexample, the illustrated crown straps 632, 634 have a looser knit whichenhances breathability in the area near the top of the patient's head.In contrast, the lower headgear straps 650 have a tight knit whichcreates a more rigid strap for stabilizing the mask. The top strap 640includes a thinned region 642 designed to avoid obstruction of thepatient's vision.

Referring to FIGS. 11 and 11A, a knitted strap 1100 includes a topportion 1102, a rear portion 1104, and a lower portion 1106. The lowerportion 1106 may bifurcate or branch out at a junction to form the topportion 1102 and the rear portion 1104. The angular orientation of thetop portion 1102 may be different compared to the rear portion 1104 e.g.the top portion 1102 may extend at about 30-110 degrees, or about 90degrees or perpendicular to the rear portion 1104. The direction of theknit, or the grain or course 1150 of the knit, may be altered to adjustthe shape or stretch of the fabric in certain areas. For example, thegrain or course 1150 may be configured to curve the strap at a cheekregion to avoid obstructing the patient's eyes. Further, as shown inFIG. 11A, the grain or course 1150 may curve, as shown by the arrows B,to a split thereby forming the top portion 1102 and the rear portion1101. Such configurations of the top portion 1102 and the rear portion1101 may stabilize the straps in position on the patient's head and thusbetter enable the strap 1100 to hold a mask assembly on a patient's facein a manner that enhances the seal with the patient's face.

The strap 1100 may support a patient interface 1130 (e.g., a nasal mask)on the patient's face. A connector 1120 may be used to attach the strap1100 to the patient interface 1130, and a supply tube 1140 may deliverbreathable gas to the patient's airways via the patient interface. Inthe illustrated example, the patient interface 1130 is positioned underthe patient's nose and seals against the external surfaces of thepatient's nose.

The headgear of the disclosed technology may further comprise a pocket,tunnel, layers and/or ribs. Such structures may be formed in one pieceby circular or flat knitting. The pockets or tunnels may be reinforcedwith materials having a higher stiffness or rigidity than the knittedtextile, thereby rigidizing the headgear. Rigidizing the headgear maybetter stabilize the mask in position on the user's face. Materials usedfor rigidizing the headgear may include plastics such as nylon,polypropylene, polycarbonate, or higher stiffness textiles such asbraided ropes. Preferably, the rigidizing of the headgear may bepositioned at boney regions of the patient's head, for example thecheeks, occiput or crown. The reinforcing structure may be insertedduring the knitting process, for example, a stiffer or flatter yarn or arigid polymer element may be inserted into the knit construction, duringor after the knitting process. The strands or rigid components wouldfunction to withstand tension and bear the stresses e.g., due totightening of the headgear straps for therapy, or to stabilise the maskbetter, or would assist to act as coupling or fastening agents to attachthe headgear piece(s) to the mask interface.

Alternatively, the pockets or tunnels may be cushioned to add comfort.For example, pockets or tunnels may be filled with foam, gel, floatingyarn, looped yarn or other cushioning material.

Preferably, the headgear is formed by flat knitting or circularknitting, wherein the headgear has selvedges. That is, the headgear maybe formed to have a finished configuration such that the ends of theyarns used to construct the headgear are substantially absent from theedges of the headgear components. An advantage of fashioning theheadgear components to the finished shape is that the yarns are notbeing cut, and are thus less likely to unravel and may require fewerfinishing steps. By forming finished edges, the integrity of theheadgear is maintained or even strengthened and fewer or nopost-processing steps are required to either (1) prevent unravelling ofthe headgear component and/or (2) create an edge that is distinct yetsoft (such as in ultrasonically cutting and sealing a ‘soft edge’ on afabric-foam-fabric laminate material) and/or (3) enhance the aestheticand durability characteristics of the headgear.

The headgear of the disclosed technology may be formed by a regular orirregular pique knit. A pique knit will orient a first yarn on the rightside (non-patient contacting side that is visible once headgear isdonned) and a second yarn on the wrong side (the patient contacting sidethat is not visible once the headgear is donned). That is, the yarnexposed on the right side may be different to the yarn exposed on thewrong side. For example, the yarn on the right side may have a pleasantvisual appearance and the yarn on the wrong side may have a nice handfeel for contacting the patient's skin. Alternatively, or in addition,the yarn on the right side may have a first moisture wicking propertyand the wrong side may have a second moisture wicking property. Forexample, the yarn on the right side may have a high percentage ofmicrofiber having a first moisture wicking property and the wrong sidemay have a high percentage of non-microfiber having a second moisturewicking property.

The headgear may be preferably formed as a unitary knit structure whichmay also be uniform in material and properties, for simplicity, butpreferably it will be formed as a unitary structure including varioussections that have different physical properties, joined in a seamlessmanner. The various sections may exhibit, for example but not limitedto, different degrees of strength, abrasion resistance, wear resistance,flexibility, enhanced durability, higher or lower moisture absorption(moisture absorbability), moisture-wicking ability, water affinity,breathability or air-permeability, liquid permeability, stretch orstretch-resistance, compressibility, cushioning ability, support,stiffness, recovery, fit, and form. The various sections may beconstructed to exhibit variations in directional stretch, such asfour-way stretch, or bi-directional stretch, a tailored level of stretchresistance, or no stretch. This may be achieved by, for example but notlimited to, selecting a particular yarn or knit construction type.

The headgear as a unified seamless structure may be formed in one piecewith uniform characteristics, or from two or more sections with varyingcharacteristics. The two or more headgear sections may differ by way ofusing two or more different yarns of different twist, denier, fibrecomposition, etc., thus imparting different physical properties to theheadgear structure. The two or more headgear sections may differ by wayof using two or more various knit stitch types, thus imparting uniquephysical properties to the two sections.

Whereas one region may incorporate, for example, elastane or PBT(Polybutylene terephthalate polyester) to enhance stretch, the otherregion may incorporate, for example, nylon or polyester to enhancedurability. Similarly, while one region of the headgear may incorporateyarn with one denier, the other region may include a yarn with a greateror reduced denier, crimp or texture, in order to customize thecushioning, thickness or bulk.

The two or more sections within a headgear construction may be connectedby using tuck stitches or other knit stitches that, for example, join afirst section to a second section in a seamless manner. This would beachieved by knitting the first section, then knitting the tuck stitchesbetween the first knitted section and a second knitted section, thenknitting the second section. The tuck stitches are utilized toseamlessly connect sections between wales, especially when using anarrow-tube circular knitting machine.

The headgear piece may be finished without a seam. If it is made with anun-dyed yarn, this may be achieved by finishing the knitting processwith a yarn that contains water-soluble fibres. The water-soluble fiberspermit the fabric to shrink in the dyeing process and provides aneatly-finished edge, eliminating the need to create an additional seamon the edge.

In order to enhance manufacturing efficiency, knitting machines may alsobe utilized to form a series of joined headgear components, such asstraps or crown components. That is, the knitting machines may form asingle component that includes a plurality of headgear pieces. Each ofthe headgear segments may have substantially identical shapes and sizes.Alternatively, each of the headgear pieces may even have differentshapes and sizes, which may be programmed in sequence. Moreover, a knitrelease area (which may consist of, for example but not limited to,dissolvable yarns, loosely knitted yarns, finer denier yarns oreasy-to-tear placeholder yarns) may be knitted into the series ofheadgear components in order to allow the various headgear parts, forexample, straps, to be separated without the need for cuttingoperations.

2.1.1.1 Spacer Fabric

In an example of the disclosed technology, headgear may be formed usingspacer fabric material. A spacer fabric can be defined as a textilehaving an upper ground structure or layer, a lower ground structure orlayer, and a floating or traversing yarn woven between the upper groundstructure and lower ground structure to form a matrix like textile. Theupper ground structure and lower ground structure may be formed from afabric. The upper ground structure may have different properties to thelower ground structure, for example they may have different stretch,stiffness, flexibility, hand feel, or other characteristics. The upperand lower ground structures may be substantially parallel to oneanother. Spacer fabrics may be formed by flat knitting. At least oneside (i.e. upper or lower ground structure) may be formed from a fabrichaving yarn of, for example, about 30-100 denier, 20-300 denier, or50-200 denier for a pleasant hand feel.

In the example of FIGS. 13 and 13 a, a rear portion 1310 includes aninner fabric 1320 for interfacing with a patient, an outer fabric 1330,and spacer threads 1340 joining the inner and outer fabrics. The innerfabric 1320 may be configured to be soft and capable of wicking moisturein order to enhance comfort. The outer fabric may be designed to have alow friction surface so as to enable movement while sleeping withoutdisrupting the position of the mask. The outer fabric may also have ananti-soil surface and may further include unbroken loop to facilitateattachment of straps.

In another example, headgear may be formed as a knitted tube having aninner space 1405, as shown in FIGS. 14-1 to 14-4 . A tubular headgearpiece 1400 includes an outer fiber/interfacing fabric 1430, an innerspacer fiber or pile (connecting layer) 1440, and an inner fiber/fabric1450. The tubular piece 1400 is constructed by a device having inner andouter needles 1410,1420 which may be programmed to knit the outerfiber/interfacing fabric 1430, the inner spacer fiber, and the innerfiber/fabric 1450.

The tubular piece 1400 may flatten out in use, when under tension, toform a low profile headgear piece (e.g., a strap), as shown in FIG. 14-3. Further, referring to FIG. 14-4 , a tubular strap 1460 may have avarying diameter such that a portion connecting to the rear portion 1310is wider than the ends adapted to connect to the mask. Thisconfiguration may reduce the visual obtrusiveness of the headgear strap1460.

In another example, the inner space 1405 may be configured to transitair, thus forming an air delivery conduit. PCT ApplicationPCT/AU2012/000667, filed Jun. 8, 2012, describes air delivery conduitsthat are made of textile or fabric materials. This application isincorporated herein by reference in its entirety. Such air deliveryconduits described in the PCT/AU2012/000667 application may bemanufactured to shape (or fully-fashioned) as described according to anyof the examples described in this application, and further may beimplemented into any of the examples described in this application.

Turning to FIGS. 15-1 and 15-2 , the depth or thickness of the headgearmay be varied by altering the length of the spacer yarns (spacerthreads). A headgear piece 1500 includes an inner fabric 1520, an outerfabric 1525, and spacer threads 1540. The headgear piece 1500 mayinclude thinner regions 1510 and thicker regions 1520. In the example ofFIG. 15-1 , a gradual transition between the thinner regions 1510 andthe thicker regions 1520 is formed. In contrast, a steeper transitioncan be seen in the example of FIG. 15-2 . One benefit of a tailoredcushion with differing thicknesses might be cushioning which changes inthickness to correspond to certain facial bone/muscle structure creatingcontour, comfort and padding, or thinner zones for breathability andtemperature management.

Referring to FIGS. 15-3 to 15-5 , the thickness of a strap 1530 can alsobe varied to create rigid portions 1532 and connecting portions 1534.The rigid portions 1532 may function as rigidizers or stabilizers andprovide form in certain areas of the headgear. The connecting portions1534 may include a hole or other structure utilized to connect the strap1530 to a mask.

In addition to varying the depth or thickness of the headgear, gaps maybe formed in the spacer threads. These gaps may be utilized to form ventholes in a mask or create flexible areas of the headgear, for example.In FIGS. 16 and 17 , a mask 1610 includes an inner fabric 1620, an outerfabric 1630, and spacer threads 1640. Voids 1660 in the spacer threadmay be used to create vent holes 1650 in the mask. To facilitate thisfeature, the inner 1620 and outer 1630 fabrics are thinned in the areasof the voids 1660. Ends of the mask may be welded, knit, or joined inany other suitable manner.

Alternatively, the voids 1660 may be thermoformed or otherwisecompressed to form thinned regions 1810, as shown in FIG. 18 . Thethinned regions 1810 may form hinges or areas adapted to bend theheadgear around a curve (e.g., around the patient's occiput).

In a further example, the spacer threads 1640 may be unevenly spaced tocreate less dense areas 1910 and more dense areas 1920. These areas maypermit flexibility of the headgear to be adjusted as desired. Forexample, the headgear may be stiffer (dense area 1920) at the cheek boneregion and flexible (less dense 1910) at the cheek muscle region.

In alternative examples, the headgear 520 and the headgear 630 of FIGS.5-1 and 6 may include spacer material, as shown in the cross-sectionalviews of FIGS. 20 and 21 . The spacer fabric construction may providemore cushioning, breathability, moisture management (e.g. moistureabsorbability or wicking), and/or desirability (e.g., comfort and/oraesthetic appeal).

Referring to FIG. 20 , the upper headgear strap 530 may include an innerfabric 530(1), an outer fabric 530(2), and spacer yarns. 530(3).Further, the edge of the strap 530 may be knitted to draw the outerfabric 530(2) into engagement with the inner fabric 530(1) to create anintegrated seamless edge 530(4). Alternatively, the inner and outerfabrics may be welded (e.g., ultrasonic welded) at the edge of the strap530.

Referring now to FIG. 21 , the crown strap 634 may include an innerfabric 634(1), an outer fabric 634(2), and spacer yarns 634(3).Additionally, the outer fabric 634(2) may be brushed or otherwisetreated to form unbroken loop material for receiving hook material.

Alternatively, the headgear may be constructed by braiding, crocheting,a net construction or raschel pattern, a single layer knit or a doublelayer knit such as an interlock or jersey, or even via additivemanufacture (3D printing). In the case of a basic single face fabric ordouble face knit, it may be preferable to use a textured yarn which mayprovide appropriate cushioning and bulk, to enhance comfort to thepatient.

Referring to FIGS. 4-2 to 4-4 , a warp knitted strap 420 formed ofspacer fabric is shown. The strap 420 includes an inner fabric 431, anouter fabric 433, and spacer yarns 435. The strap may be formed of nylonand/or polyester, or any other suitable materials. The inner fabric 431and the outer fabric 433 may have a soft surface having a high density.The strap may have a wider portion 422 adapted to connect to anotherheadgear member (e.g., a rear portion) and a thinner portion 424 adaptedto connect to a mask. The spacer yarns or pile may be formed to be shearresistant. The inner and outer fabrics are knitted together at theselvedges 437 to enclose the spacer pile. In another example, as shownin FIG. 4-4 , the outer fabric 433 includes unbroken loop material 440for receiving hook material.

In an example, as shown in FIG. 4-2 , d1 may be about 22.5-42.5 mm,e.g., 32.5 mm, d2 may be about 30-50 mm, e.g., 40 mm, d3 may be about152-292 mm, e.g., 222 mm, d4 may be about 11-17 mm, e.g., 14 mm, and d5may be 14-22 mm, e.g., 18 mm. Further, as shown in FIG. 4-3 , d1 may beabout 1.75-3.25 mm, e.g., 2.5 mm and d2 may be about 2.25-3.75 mm, e.g.,3 mm.

In FIGS. 4-5 to 4-9 , a warp knitted strap 450 includes an inner fabric461, an outer fabric 463, and spacer yarns 465. In contrast to the strap420 above, the strap 450 has a constant width. The spacer yarns or pilemay be formed to be shear resistant. The inner and outer fabrics areknitted together at the selvedges 467 to enclose the spacer pile. Inanother example, as shown in FIG. 4-7 , the outer fabric 463 includesunbroken loop material 470 for receiving hook material. In a furtherexample the outer fabric 463 may be elasticated to form a high-tensionouter fabric 463-1, as shown in FIG. 4-8 . The elasticated outer fabric463-1 pulls the selvedges 467 to the outer surface of the strap, and mayfunction to cause the headgear strap to curl upwards and inwards towardsthe outer fabric layer of the strap. In cross section, as shown in FIG.4-8 , the strap may have the appearance of the letter C. Thisarrangement may be advantageous in reducing facial marking as the strapdoes not have a distinct edge when pressed against the patient's skin,since the edge curls up away from the skin.

In an example, as shown in FIGS. 4-5 and 4-6 , d1 may be about 1.75-3.25mm, e.g., 2.5 mm, d2 may be about 2.25-3.75 mm, e.g., 3 mm, and d3 maybe about 11-17 mm, e.g., 14 mm.

2.1.1.2 Double Knit or Interlock

Alternatively, in accordance with another example, headgear may beformed to shape having an inner and outer face with no space in betweenthese faces. FIG. 22-1 is a schematic representation of a double knitand FIGS. 22-2A and 22-2B illustrate an interlock knit. In FIGS. 22-1,22-2A and 22-2B, an inner fabric 2210 and an outer fabric 2220 areknitted in such close proximity that they form a double-faced fabricsuch as interlock, double knit or double jersey. As shown in FIG. 22-1 ,the inner 2210 and outer 2220 fabrics are knitted at the same time witha spacer yarn 2230 that pulls the inner 2210 and outer 2220 fabriclayers together. However, in the example of FIGS. 22-2A and 22-2B, theinner 2210 and outer 2220 fabrics are knitted concurrently (at the sametime) without the need for an additional spacer yarn in a mannercommonly known as interlock, whereby there are two sets of yarns whichform the inner and outer fabric respectively.

Double faced or knit fabrics may be beneficial for use in headgear asthe fabric may be flatter (i.e. thinner in fabric thickness, not thinnerin strap width) than most conventional headgear materials (e.g. foamlaminate) so as to be as unobtrusive as possible for the patient, butmore substantial, dense, durable, robust or stiff than a single-knit. Adouble knit fabric may also permit a first characteristic orpattern/structure on one side of the fabric with a second characteristicor pattern/structure on the opposite side of the fabric. For example, asoft yarn may be provided on the patient contacting side, and a moredurable yarn or construction on the non-patient contacting side. In afurther example, a wicking microfiber may be provided on the patientcontacting side and a hydrophilic material may be provided on thenon-patient contacting side. In a further example a cotton yarn may beprovided on the patient contacting side and a polyester outer may beprovided on the non-patient contacting side. A double knit fabric may bepreferable to a spacer fabric as the double knit may be less expensiveand less complex due to the smaller number of layers.

2.1.1.3 Stitching

The number of stitches can be adjusted to enhance comfort, fit and/orperformance. For instance, the number of stitches may be varied tocreate ruffles which may function to reduce facial marking. In theexample of FIG. 23 , a mask 2305 is supported by headgear 2310. The maskincludes a seal portion 2307 which seals against the patient's face. Theheadgear 2310 includes straps 2312 and may also include an upper strap2314 to assist in stabilizing the mask. The number of stitches through amiddle portion 2320 of the straps 2312 is less than the number ofstitches near the outer edge of the straps. The increased number ofstitches at the edge portion causes the strap to form ruffles 2330. Itwill be understood that the number of stitches may be adjusted in anyportion of the headgear to achieve a desired fit.

Referring back to FIGS. 13 and 13 a, the number of stitches in the rearportion 1310 may be adjusted to cause the rear portion to form a shapeconfigured to conform to a patient's head. The truncated cone shape inFIG. 13 is shown to illustrate an example of adjusting the number ofstitches to change the shape. For example, a distal portion 1312 of therear portion 1310 may have fewer stitches than a proximal portion 1314.In an example, the distal portion may be comprised of 100 stitches andthe proximal portion may be comprised of 200 stitches. This arrangementmay cause the proximal portion to have an increased diameter therebyflaring outwardly into a truncated cone shape.

2.1.1.4 Variable Thread Count

In another example, the thread count may vary across the fabric toenhance comfort, fit and/or performance. For example, the thread countmay be higher in regions requiring greater stiffness (e.g., cheekregion, occiput). In regions (e.g., along the straps) where a lowerstiffness is desired, however, the thread count may be lower therebypermitting the material to flex more easily.

The thread count, and therefore the stiffness, may be determined by thetype of yarn, the type of stitch (e.g., a criss-cross stitch may bestiff), and the distance between stitches.

2.1.1.5 Rigidizer

The headgear may include one or more rigidizers that are structured toadd rigidity, stiffness and/or stability to the headgear and anchor theheadgear in position in use. In an example, a rigidizer is formedintegrally with a strap. For instance, in FIGS. 25-1 and 25-2 , yarnhaving a higher stiffness than the surrounding yarn of the headgear 2500may be knitted in specific regions (e.g., cheek region or crown region)to form a rigidizer 2510. The rigidizer 2510 may stiffen the headgear toprovide stability for the mask. In addition, the rigidizer 2510 may beshaped to form a headgear clip 2520 for attachment to a patientinterface 2530 (e.g., nasal mask).

In another example, the yarn forming the rigidizer 2510 may be melted orfused to further stiffen the yarn into a welded rigidizer 2610, as shownin FIG. 26 . Preferably, the rigidizer yarn has a lower melt temperaturethan the surrounding yarn such that the welded rigidizer 2610 can beformed without deforming the surrounding yarn. In an example, therigidizer yarn includes polypropylene and the surrounding yarn includesnylon or other non-plastic material such as cotton or wool.

The knitted headgear component may incorporate a thermoplastic yarn thatis fused in different regions of the knitted component to impartdifferent properties. By heating the thermoplastic polymer materials,adjacent yarns, filaments, or fibers may fuse to each other in thoseareas to lock the knit loops together, thereby increasing stiffness orwear-resistance or stability of the mask on the patient's face. As analternative, the entirety of the knitted headgear component may beformed from yarns that incorporate thermoplastic polymer materials, andonly specific portions corresponding with fused areas may be heated tomodify the properties.

The rigidizer may be formed by a flat tool 2650, as shown in FIG. 26 ,or a curved tool 2750, as shown in FIG. 27 . In FIG. 27 , a curvedheadgear 2700 having a curved rigidizer 2710 is formed.

The inner or outer layer of headgear fabric may be formed to include aslit (or gap). A rigid or semi-rigid element may be inserted through theslit to form a support positioned between the inner layer and the outerlayer of the headgear. In an example shown in FIG. 14-5 , a similarhollow structure (to FIGS. 14-1 to 14-4 ) could also be knitted in aflattened-out manner, for instance on a warp knitting machine, byconcurrently knitting an outer fabric 461-2, that interfaces with thepatient, to a layer of spacer yarns 465-2, which at the same time isknitted to an inner fabric 463-2 that encases the spacer yarns, which iscovered in turn by knitting a pocket layer 469-2 that forms a gap 470-2(or pocket). The pocket layer 469-2 is connected to the outer fabric461-2, the spacer yarns 465-2 and/or the inner fabric 463-2 only nearthe selvedge 467-2 of the knitted structure.

As shown in FIGS. 14-6 and 14-6A, the gap 470-2 could form a hollowpocket in a strap 450-1, for example, which may be filled with aseparate rigidizer 472-2, for example, or may be used to locate anotherrelated mask component or attachment mechanism. The spacer fabricprovides a soft cushioning between a hard part (e.g., the rigidizer472-2) and the patient's face, and the pocket functions to locate a hardplastic part or cushion attachment into the soft fabric headgear strapencasement, which may be fastened in place by, for example, friction,clips, adhesives, heat laminate or overstitching.

2.1.1.6 Yarn

Yarn may be utilized to create the headgear of the disclosed technology.

The yarn may be synthetic, and may be twisted or textured, and could bemade from, but not limited to nylon, polyester, acrylic, rayon, orpolypropylene. The yarn could be a conventional staple yarn, amicrofiber yarn, or combination of both.

The yarn may incorporate an elastane fiber or filament to providestretch and recovery properties, such as fibers bearing the LYCRAtrademark from the DuPont company.

The yarn may be made of synthetic materials, or natural fibres such ascotton, wool or bamboo, or natural filament such as silk.

The yarns used to construct any component of the headgear may be formedof a monofilament or a plurality of single filaments, that is, amultifilament yarn.

The yarn may include separate filaments that are each formed ofdifferent materials. The yarn may also include filaments that are eachformed of two or more different materials, such as bicomponent yarn withfilaments having a sheath-core configuration or two halves formed ofdifferent materials. Different degrees of twist or crimping, as well asdifferent deniers, may affect the properties of the headgear.

The materials utilized to construct the headgear components may be maderecyclable or biodegradable, for example, the yarns may includerecyclable or biodegradable fibers or filaments.

Areas of the headgear subject to greater wear (for example but notlimited to areas or regions coming into contact with a patient'spillow), such as an area of headgear located at the back of the head ornape of the neck, may possibly be more densely fabricated and may thusbe a heavier weight and less extensible. Conversely, this area may besubject to the greatest amount of moisture accumulation through sweat,and therefore may need to be made of a thin, yet strong, net-likeconstruction with a custom aperture pattern. In this case, theabrasion-resistance may need to be inherent in the yarn properties only.

2.1.2 3D Printing

In another example, headgear may be manufactured to shape using a 3Dprinter. As shown in FIG. 28 , a 3D printer may be used to print aplurality of connected links 2802 thereby forming a flexible 3D printedtextile 2804. Referring to FIG. 29 , a headgear piece 2900 may be formedto include a rigidizer 2920. The rigidizer includes holes 2922 throughwhich the links of the textile 2904 may pass as the textile is printedto integrate the textile and the rigidizer. The rigidizer could be madefrom any suitable material (e.g., a polymer such as Nylon 12 or asintered solid from a metal powder, or any other material able to usedfor an additive manufacture process). As the additive manufacture (“3DPrinting” process technologies improve, it is envisioned that thematerial selection will become broader for the purposes of 3D printingtextiles, with the optional inclusion of a rigid component. Structurecould be inherent in material or by virtue of structure.

Further, as shown in FIG. 30 , a 3D printed strap 3004 may be integratedinto holes 3012(1), 3014(1) of male and female clips 3012, 3014.

2.2 Custom Headgear

Custom headgear may be manufactured for an individual patient inaccordance with an example of the disclosed technology. Data regardingthe shape and size of the patient's head is acquired (e.g., via photo,3D scan). Measurements that may be used to manufacture a custom headgearmay include the circumference of the patient's crown, length from theocciput to the crown, and the position of the patient's ears, eyes andnose. Visual modeling software (e.g., CADCAM) operating on a computermay create a custom headgear model according to the patient'smeasurements and needs. This model may then be sent to a machine (e.g, aknitting machine or 3D printer) for creation of the headgear.

It is noted that features of the disclosed technology have beenparticularly described with reference to headgear. However, all of thefeatures described in relation to headgear may also be usable in anymask constructed in accordance with the disclosed technology.

While the technology has been described in connection with severalexamples, it is to be understood that the technology is not to belimited to the disclosed examples, but on the contrary, is intended tocover various modifications and equivalent arrangements included withinthe spirit and scope of the technology. Also, the various examplesdescribed above may be implemented in conjunction with other examples,e.g., one or more aspects of one example may be combined with one ormore aspects of another example to realize yet other examples. Further,each independent feature or component of any given assembly mayconstitute an additional example. In addition, while the technology hasparticular application to patients who suffer from OSA, it is to beappreciated that patients who suffer from other illnesses (e.g.,congestive heart failure, diabetes, morbid obesity, stroke, bariatricsurgery, etc.) can derive benefit from the above teachings. Moreover,the above teachings have applicability with patients and non-patientsalike in non-medical applications.

What is claimed is:
 1. A mask system for use in treating a patient forsleep disordered breathing, comprising: a mask adapted to seal againstthe patient's face thereby forming a breathing cavity to deliverpressurized air to the patient's airways; and a headgear assembly tosupport the mask in position on the patient's face for positive pressuretreatment of the patient, the headgear assembly including: at least oneheadgear component including spacer fabric having an inner layer, anouter layer and spacer threads joining the inner layer and the outerlayer, the inner layer being adapted to interface with the patient andthe outer layer forming a non-patient contacting side of the at leastone headgear component, the inner layer having a first characteristicassociated with at least one property and the outer layer having asecond characteristic associated with the at least one property, thefirst characteristic being different from the second characteristic,each spacer thread having a first point along its longitudinal lengthconnected to the inner layer and a second point along its longitudinallength connected to the outer layer, the first point being spaced apartfrom the second point in a thickness direction of the spacer fabric,wherein lengths of the spacer threads from the respective first pointsto the respective second points vary along the at least one headgearcomponent to vary a thickness of the spacer fabric so as to form thinnerregions and thicker regions of the spacer fabric, and wherein a densityof the spacer threads varies along the at least one headgear componentto form a first area and a second area, the first area being more densethan the second area, the first area having increased stiffness ascompared to the second area and the second area having increasedflexibility as compared to the first area.
 2. The mask system of claim1, wherein the at least one property is stretchability, stiffness,flexibility, or hand feel.
 3. The mask system of claim 1, wherein theinner layer is configured to be soft and capable of wicking moisture. 4.The mask system of claim 1, wherein the outer layer has a low frictionsurface to enable movement while sleeping without disrupting theposition of the respiratory mask.
 5. The mask system of claim 1, whereinthe outer layer is elasticated to form a high-tension outer fabric thatcauses the headgear component to curl upwards and inwards towards theouter layer.
 6. The mask system of claim 1, wherein the thickness variesto alter a cushioning effect of the at least one headgear component tocorrespond to the patient's facial bone/muscle structure and/or to alterbreathability.
 7. The mask system of claim 1, wherein the at least oneheadgear component includes at least one thick portion which functionsas a rigidizer to provide form to the at least one headgear component.8. The mask system of claim 1, wherein the spacer fabric has at leastone portion that is void of spacer threads, the at least one portionforming a flexible region that is thinner and more flexible than atleast one second portion of the spacer fabric.
 9. The mask system ofclaim 8, wherein the flexible region forms a hinge configured to allowthe at least one headgear component to bend around a curve of thepatient's head in use.
 10. The mask system of claim 1, wherein the outerlayer includes unbroken loop material.
 11. The mask system of claim 1,wherein the spacer threads are shear resistant.
 12. The mask system ofclaim 1, wherein the inner layer is knitted to the outer layer to form aseamless edge.
 13. The mask system of claim 1, wherein the inner layerand the outer layer are ultrasonically welded at an edge of the at leastone headgear component.
 14. The mask system of claim 1, wherein the atleast one headgear component comprises a strap.
 15. The mask system ofclaim 1, wherein the at least one headgear component comprises a rearportion adapted to engage the patient's occiput.
 16. The mask system ofclaim 1, wherein the headgear assembly includes at least one crown straparranged to pass over or around a crown of the patient's head when themask is worn.
 17. The mask system of claim 16, wherein the headgearassembly includes a top strap interconnecting the at least one crownstrap and the mask.
 18. The mask system of claim 17, wherein theheadgear assembly includes a pair of lower headgear straps.
 19. The masksystem of claim 1, wherein the headgear assembly forms a shape, when theheadgear is not being worn, that is configured to conform to thepatient's head.
 20. The mask system of claim 1, wherein the headgearassembly forms a shape that is configured to conform to the patient'socciput.